Are Wearables Medical Devices Requiring a CE-Mark in the EU? (Covington)
Publication date: 18/01/
Wearable watches that help consumers obtain a better understanding of their eating patterns; wearable clothes that send signals to treating physicians; smart watches: they are but a few examples of the increasingly available and increasingly sophisticated “wearables” on the EU market. These technologies are an integrated part of many people’s lives, and in some cases allow healthcare professionals to follow-up on the condition or habits of their patients, often in real-time. How do manufacturers determine what wearables qualify as medical devices? How do they assess whether their devices need a CE-mark? Must they differentiate between the actual “wearable” and the hardware or software that accompanies them? In this short contribution, we briefly analyze some of these questions. The article first examines what “wearables” are, and when they qualify as a medical device under current and future EU rules. It then addresses the relevance of the applicability of EU medical devices rules to these products. The application of these rules is often complex and highly fact-specific.
What Are “Wearables”?
There is no legal definition of “wearables” in the EU, but the European Commission proposed a definition of smart wearables in its Smart Wearables Reflection and Orientation Paper. The paper states that “smart wearables are body-borne computational and sensory devices which can sense the person who wears them and/or their environment. Wearables can communicate either directly through embedded wireless connectivity or through another device (e.g. a smartphone). (…) Smart wearables may have control, communication, storage and actuation capabilities.”
Thus, the term “wearables” effectively covers a very broad range of items and technologies and the market is evolving continuously. The list of wearables is indeed quite long. Some examples include: smart watches, fitness trackers, bracelets, smart patches, body-worn smart clothes and smart fabrics, smart shoes, smart glasses with sensors, virtual reality headsets, exoskeletons (wearable robots), smart jewelry (e.g. ear rings to monitor sleep quality), etc. Indeed, the term could also cover implantable items, but this article does not address the specific EU law requirements on implantable medical devices.
Are Wearables Medical Devices Under the EU Medical Devices Rules?
Analysis under the Current Medical Devices Directive
The answer to what may appear to be a simple question is quite complex, primarily because the application of relevant EU legislation and guidance is highly fact-specific. Under the Medical Devices Directive 93/42/EEC (“MDD”), a medical device is defined as “any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination” and “intended by the manufacturer to be used for human beings” for purposes of (among other things) “diagnosis, prevention, monitoring, treatment or alleviation of disease, [or of an] injury or handicap”, or for the “investigation, replacement or modification of the anatomy or of a physiological process (…).”
As a general rule, when devices are intended to be used for medical purposes, they qualify as a medical device. The term “medical purposes” is, however, not defined and subject to interpretation.
Below we briefly assess the key components of this definition and how they may apply to wearables:
1. “Intended by the manufacturer to be used” for specific purposes: Intended purpose is “the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials” (Article 1(2)(g) of the MDD). The European Court of Justice (“ECJ”) considers that “[where] a product is not conceived by its manufacturer to be used for medical purposes, its certification as a medical device cannot be required” as it will not fall within the ambit of the MDD (Case C-219/11 Brain Products GmbH V Biosemi VOF and Others). Therefore, how the manufacturer advertises and describes the product may have an important bearing on the classification as a medical device.
Example: a bracelet monitoring heart rate. This device could, depending on the circumstances, fall outside the scope of the medical devices rules. The analysis is not straightforward, however. On the one hand, one might take the view that the bracelet is used for the investigation of a physiological process, which would trigger a classification as a medical device. On the other hand, if the heart rate monitoring does not serve any medical purpose — but is intended, for instance, for the user’s own information during running or other physical exercise — it may not be subject to the medical devices rules. This is supported by MEDDEV guidance 2.1/6, which provides that “software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device. Software for general purposes when used in a healthcare setting is not a medical device.” On that basis, the heart rate monitoring bracelet would not qualify as a medical device when used for general fitness purposes, but could qualify as a medical device if its intended purpose relates for instance, to the monitoring or prevention of cardiac disease.
2. “Whether used alone or in combination”: The actual wearable (clothes, watch, etc.) will often be accompanied by a processing unit (smartphone, computer, etc.). In that regard, the concept of “accessory” under the MDD is relevant. The Directive defines an accessory as “an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device” (Article 1(2)(b) of the MDD). Accessories are also subject to the substantive requirements of the MDD and require a CE-mark.
Example: a smart watch that is used for various purposes and is marketed with an app. Again, whether these items qualify as (a) medical device(s) depends on various factors. The first question is whether the item(s) is(are) device(s) in its(their) own right or rather accessory(ies) to one another. The MHRA’s guidance on ‘Medical device stand-alone software including apps’ for instance, provides that “software on a mobile device linked wirelessly to a monitoring device to record data” should be considered as an accessory as it is “a product intended to enable a medical device to fulfil its intended function.” Depending on the functionalities of the watch and what app it is meant to be used for, one could indeed qualify as an accessory to the other.
Second, much will depend on the intended purpose of the watch or the app. An analogy with an example given in EU-level guidance sheds more light on this. According to the Manual on Borderline and Classification in the Community regulatory framework for medical Devices (October 2018), a mobile app for managing pictures of moles would not qualify as medical device software, whereas a mobile app for scientifically assessing the moles would, because it performs an action on data other than just storage, for the medical benefit of individual patients. Furthermore, based on the MEDDEV guidance 2.1/1, products with multiple purposes that may be used occasionally in a medical environment are normally not medical devices, unless a specific medical intended purpose is assigned to them. The ECJ has recently confirmed this analysis and considers that “software, of which at least one of the functions makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device within the meaning of [the MDD], even if that software does not act directly in or on the human body.” In addition, the Court referred to MEDDEV guidance 2.1/6 and clearly stated that “in respect of medical software comprising both modules that meet the definition of the term ‘medical device’ and others that do not meet it and that are not accessories within the meaning of Article 1(2)(b) of Directive 93/42, only the former fall within the scope of the directive and must be marked CE” (Case C-329/16 SNITEM and Philips France V Premier Ministre and Ministre des Affaires sociales et de la Santé). This shows that the classification of the smart watch and the app it is meant to be used with largely depends on the intended purposes of both items.
Analysis under the Future Medical Devices Regulation
The MDD will be replaced by the Medical Devices Regulation 2017/745 (“MDR”) as from 26 May 2020 (be it with important transitional measures). The new definition of medical device under the MDR is not very different from the definition of the MDD, but there are some important nuances that may have a bearing on the classification of certain wearables. For instance, the intended purposes under the new medical device definition have been broadened to also include “prediction” and “prognosis.” These new possibilities may bring certain digital health care technologies, capable of predicting the likelihood of people incurring for instance, certain illnesses, within definition of medical device. On balance, we do not foresee a dramatic impact of the new medical devices definition on wearables. That said, some wearables, such as certain digital health apps, that are currently not subject to the EU medical devices rules, will be in the very near future.
Why Does the Classification of Wearables as Medical Devices Matter?
Under the MDD, medical devices manufacturers are subject to various regulatory obligations. In particular, the MDD requires (among other things) that a CE-mark be applied to medical devices before they are placed on the EU market and that a Declaration of Conformity be drawn up. Manufacturers are only allowed to apply a CE-mark if the device is compliant with the substantive requirements of the MDD (e.g., safety requirements). Establishing whether a device is compliant with the medical devices rules requires compliance with the so-called “conformity assessment procedures.”
The substantive requirements and the conformity assessment procedures are more complex and burdensome under the MDR. One of the changes, for instance, is that manufacturers will less often be allowed to self-certify compliance with the medical devices rules but will need to involve notified bodies to conduct the assessment for them. For some wearables, self-certification will continue to suffice; for others, notified body involvement becomes necessary. Whether notified body involvement is needed largely depends on the classification of the device. The MDD classifies devices as class I to class III devices, depending on the health risks of the device. A large part of the currently marketed wearables in the EU that meet the medical device definition qualify as class I devices under the MDD. Most software appliances, for instance, currently qualify as class I devices, and as a consequence do not need to be certified by a notified body. The MDR also contains more sophisticated classification rules when it comes to software. Annex VIII of the Regulation provides that “software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.” Wearables that are currently class I devices could become class IIa or IIb under the MDR, which has important implications, such as the need for notified body certification. Therefore, a correct analysis of the classification as a medical device under the EU rules is of paramount importance for players operating in the diverse wearables market.